Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging.

Background: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by transesophageal echocardiography (TEE). As each patient has unique anatomy and acoustic window, adding transthoracic echocardiography (TTE) and cardiac CT could improve procedural planning and guidance. Objectives: We aimed to assess T-TEER success and outcomes of a personalized guidance approach, based on multimodality imaging (MMI) of patient-tailored four right-sided chamber views (four-right-ch), as depicted by CT, TTE, TEE and fluoroscopy. Methods: Patients were assigned to MMI or classical TEE guidance, depending on TTE acoustic window. In MMI patients, planning included cardiac CT, which determined the fluoroscopic angulations of the specific four-right-ch, while guidance relied heavily on TTE, with minimal intermittent TEE for leaflet grasping and result confirmation. Both TTE and TEE were matched to respective CT and fluoroscopy four-right-ch. TR severity and quality of life (QoL) parameters were assessed from baseline to 12 months. Results: A total of 40 T-TEER patients were included, with 17 procedures guided by MMI and 23 solely by TEE. Baseline characteristics were similar between groups, e.g., age (83.1 ± 4.1 vs. 81 ± 5.3, p = 0.182) or STS-Score (11.1 ± 7.4% vs. 10.6 ± 5.9%, p = 0.813). The primary efficacy endpoint of ≥one-grade TR reduction at 30 days was 94% (16/17) in MMI vs. 91% (21/23) in TEE patients, with two or more TR grade reduction in 65% vs. 52% (p = 0.793). Device success was overall 100%, with no device-related complications, but three TEE-associated cases of gastrointestinal bleeding in the TEE-only group. By 12 months, all 15 MMI and 19 TEE survivors improved NYHA functional class and QoL, e.g., Kansas City Cardiomyopathy Questionnaire Score Δ29.6 ± 6.7 vs. 21.9 ± 5.8 (p = 0.441) pts., 6-min walk distance Δ101.5 ± 36.4 vs. 85.7 ± 32.1 (p = 0.541) meters. Conclusions: In a subset of patients with good TTE acoustic window, MMI guidance of T-TEER is effective and seems to avoid gastroesophageal injuries caused by TEE probe manipulation. TR reduction, irrespective of guidance method, impacts long-term QoL.

Two 'firsts' in a patient with tricuspid valve infective endocarditis following edge-to-edge repair: a case report.

Background: Tricuspid regurgitation (TR) is associated with increased morbidity and mortality. As many elderly TR patients are deemed inoperable, transcatheter edge-to-edge repair (T-TEER) is arising as a viable treatment option. Though procedural safety aspects seem excellent, long-term risks cannot be ignored, including the feasibility of cardiac pacing by endovascular lead implantation at a later time, as well as T-TEER device-related infective endocarditis (IE), in the context of systemic infection. Case summary: We present the case of an 80-year-old man with recurrent admissions for right heart failure due to massive TR, despite successful percutaneous mitral valve repair. The patient was turned down for surgery and eventually underwent T-TEER, with successful TR reduction to mild-to-moderate and improvement in quality of life. Five months later, the patient was admitted for symptomatic bradycardia and the first reported pacemaker implantation after T-TEER with a specific tricuspid valve device was performed. Lead implantation was guided by transoesophageal echocardiography, and did not worsen residual TR. Two years later, the patient presented with device-related tricuspid valve IE, again a 'first' following T-TEER. Despite antimicrobial therapy, the vegetation embolized through the atrial septal defect caused by prior mitral-TEER and triggered an ischaemic stroke. Furthermore, sepsis led to multiorgan failure and eventually death. Discussion: Tricuspid regurgitation is an individual predictor of morbidity and mortality, frequently found in elderly, and should be addressed in symptomatic inoperable patients. With the rise of interventional treatment, new challenges face long-term follow-up and treatment after percutaneous repair. This case report underscores the feasibility of endovascular pacemaker lead implantation after T-TEER, while it points to the risk of device-related tricuspid valve IE.

Differential Effects of Erythropoietin Administration and Overexpression on Venous Thrombosis in Mice.

BACKGROUND: Deep vein thrombosis (DVT) is a common condition associated with significant mortality due to pulmonary embolism. Despite advanced prevention and anticoagulation therapy, the incidence of venous thromboembolism remains unchanged. Individuals with elevated hematocrit and/or excessively high erythropoietin (EPO) serum levels are particularly susceptible to DVT formation. We investigated the influence of short-term EPO administration compared to chronic EPO overproduction on DVT development. Additionally, we examined the role of the spleen in this context and assessed its impact on thrombus composition. METHODS: We induced ligation of the caudal vena cava (VCC) in EPO-overproducing Tg(EPO) mice as well as wildtype mice treated with EPO for two weeks, both with and without splenectomy. The effect on platelet circulation time was evaluated through FACS analysis, and thrombus composition was analyzed using immunohistology. RESULTS: We present evidence for an elevated thrombogenic phenotype resulting from chronic EPO overproduction, achieved by combining an EPO-overexpressing mouse model with experimental DVT induction. This increased thrombotic state is largely independent of traditional contributors to DVT, such as neutrophils and platelets. Notably, the pronounced prothrombotic effect of red blood cells (RBCs) only manifests during chronic EPO overproduction and is not influenced by splenic RBC clearance, as demonstrated by splenectomy. In contrast, short-term EPO treatment does not induce thrombogenesis in mice. Consequently, our findings support the existence of a differential thrombogenic effect between chronic enhanced erythropoiesis and exogenous EPO administration. CONCLUSION: Chronic EPO overproduction significantly increases the risk of DVT, while short-term EPO treatment does not. These findings underscore the importance of considering EPO-related factors in DVT risk assessment and potential therapeutic strategies.

Machine learning identifies pathophysiologically and prognostically informative phenotypes among patients with mitral regurgitation undergoing transcatheter edge-to-edge repair.

AIMS: Patients with mitral regurgitation (MR) present with considerable heterogeneity in cardiac damage depending on underlying aetiology, disease progression, and comorbidities. This study aims to capture their cardiopulmonary complexity by employing a machine-learning (ML)-based phenotyping approach. METHODS AND RESULTS: Data were obtained from 1426 patients undergoing mitral valve transcatheter edge-to-edge repair (MV TEER) for MR. The ML model was developed using 609 patients (derivation cohort) and validated on 817 patients from two external institutions. Phenotyping was based on echocardiographic data, and ML-derived phenotypes were correlated with 5-year outcomes. Unsupervised agglomerative clustering revealed four phenotypes among the derivation cohort: Cluster 1 showed preserved left ventricular ejection fraction (LVEF; 56.5 ± 7.79%) and regular left ventricular end-systolic diameter (LVESD; 35.2 ± 7.52 mm); 5-year survival in Cluster 1, hereinafter serving as a reference, was 60.9%. Cluster 2 presented with preserved LVEF (55.7 ± 7.82%) but showed the largest mitral valve effective regurgitant orifice area (0.623 ± 0.360 cm2) and highest systolic pulmonary artery pressures (68.4 ± 16.2 mmHg); 5-year survival ranged at 43.7% (P-value: 0.032). Cluster 3 was characterized by impaired LVEF (31.0 ± 10.4%) and enlarged LVESD (53.2 ± 10.9 mm); 5-year survival was reduced to 38.3% (P-value: <0.001). The poorest 5-year survival (23.8%; P-value: <0.001) was observed in Cluster 4 with biatrial dilatation (left atrial volume: 312 ± 113 mL; right atrial area: 46.0 ± 8.83 cm2) although LVEF was only slightly reduced (51.5 ± 11.0%). Importantly, the prognostic significance of ML-derived phenotypes was externally confirmed. CONCLUSION: ML-enabled phenotyping captures the complexity of extra-mitral valve cardiac damage, which does not necessarily occur in a sequential fashion. This novel phenotyping approach can refine risk stratification in patients undergoing MV TEER in the future.

Frequency of subclavian artery stenosis in patients with mammarian artery coronary bypass and suspected coronary artery disease progression.

We retrospectively analyzed patient records of all patients with a history of internal mammarian artery (IMA) coronary bypass undergoing coronary angiography at two cardiovascular centers between January 1st 1999 and December 31st 2019. A total of 11,929 coronary angiographies with or without percutaneous coronary intervention were carried out in 3921 patients. Our analysis revealed 82 (2%) patients with documented subclavian artery stenosis. Of these, 8 (10%) patients were classified as having mild, 18 (22%) moderate, and 56 (68%) severe subclavian artery stenosis. In 7 (9%) patients with subclavian artery stenosis, angiography revealed occlusion of the IMA graft. 26 (32%) patients with severe subclavian artery stenosis underwent endovascular or surgical revasculararization of the subclavian artery. In this retrospective multicenter study, subclavian artery stenosis was a relevant finding in patients with an internal mammarian artery coronary bypass graft undergoing coronary angiography. The development of dedicated algorithms for screening and ischemia evaluation in affected individuals may improve treatment of this potentially underdiagnosed and undertreated condition.

Transcatheter Tricuspid Valve Repair in Prohibitive Risk Patients: Impact on Quality of Life and Major Organ Systems.

BACKGROUND: Percutaneous repair for severe tricuspid regurgitation (TR) is emerging as a viable option, but patient selection is challenging and predetermined by comorbidities. This study evaluated mid-term outcomes of transcatheter tricuspid valve repair (TTVR) in very sick inoperable patients and explored the concept of risk-based therapeutic futility. METHODS: TTVR patients treated in our centre were prospectively assigned to prohibitive-risk (PR) and high-risk (HR) subgroups, based on Society of Thoracic Surgeons (STS) Score, frailty indices, and major organ system compromise. Efficacy and safety outcomes were compared at baseline, 30 days, and 6 months. RESULTS: Thirty-three patients (mean age 81.9 ± 5.1 years) completed follow-up from May 2021 to March 2022: 18 PR (mean STS Score 15.5 ± 7%) and 15 HR (mean STS Score 6.4 ± 1.7%). The primary efficacy end point of at least 1 grade of TR reduction by 30 days was recorded in 93.9% of all patients, with no device-related adverse events. Improvement in initial New York Heart Association functional class III/IV occurred in 74% of PR and 93% of HR patients. Six-minute walk test increased by 81 ± 43.6 metres (P < 0.001) and 85.8 ± 47.9 metres (P < 0.001), respectively. Renal function tests improved by 15% (P = 0.048) and 7% (P = 0.050), while liver enzymes decreased by 18% (P = 0.020) and 28% (P = 0.052). Right ventricular systolic function increased in both subgroups by at least 24% (P < 0.001). Six-month mortality was 12.1%, with 6 hospitalisations for acute heart failure. CONCLUSIONS: TR reduction significantly affected quality of life, functional capacity, cardiac remodelling, and multiorgan involvement similarly in PR and HR patients. TTVR is feasible in very sick symptomatic patients, regardless of predicted risk.

Diabetes mellitus and femoropopliteal in-stent restenosis.

Background: The influence of diabetes mellitus (DM) on recurrent in-stent restenosis (ISR) of femoropopliteal arteries remains understudied. We investigated whether DM has an impact on recurrent restenosis after femoropopliteal stenting in patients included in the dRug-coatEd balloon angioPlasty for femoropopliteAl In-stent Restenosis (REPAIR) cooperation. Patients and methods: The REPAIR cooperation pooled the patient-level data from 3 randomized trials in which patients with ISR of femoropopliteal arteries received either drug-coated balloon (DCB) or plain balloon angioplasty. For this analysis, patients were divided in two groups based on whether they had or had not a DM diagnosis at the time of enrollment. The primary outcome was target lesion revascularization (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were death, Rutherford class improvement and ankle-brachial index at follow-up. Results: 256 patients (DM, n=99 vs. non-DM, n=157) with 12-month follow-up were included in the analysis. Compared to non-DM patients, DM patients displayed no difference in terms of TLR [adjusted hazard ratio (95% Confidence intervals): 0.96 (0.55, 1.69), p=0.89] and recurrent ISR [1.04 (0.61, 1.77), p=0.88], whilst mortality was higher [9.38 (1.06, 83.11), p=0.044]. There were no differences between groups with respect to other secondary outcomes. The percutaneous treatment with DCB as compared to plain balloon angioplasty significantly reduced the risk of TLR and recurrent ISR without an excess risk of death irrespective of DM (p for interaction ≥0.70). Conclusions: In patients with femoropopliteal ISR, diabetes has a neutral effect on the risk of recurrence, but increases mortality at 12-month follow-up. DCB as compared to plain balloon angioplasty is associated with superior efficacy without trade-off in safety, regardless of diabetes.

Transthoracic guidance of percutaneous tricuspid valve repair: a case report.

BACKGROUND: Percutaneous tricuspid valve (TV) repair for tricuspid regurgitation (TR) is arising as a viable treatment option in high-risk patients and can lead to symptom control an improvement in quality of life (QoL). Newest devices have greatly increased safety and efficacy of interventional TR therapy. However, as with any emerging medical procedure, safety aspects need to be considered and procedural risks gradually reduced. CASE SUMMARY: We present the case of an 87-year-old woman with massive TR despite successful percutaneous mitral valve repair. The patient was turned down for surgery and eventually underwent percutaneous TV repair using the TriClip™ (Abbott Medical) device. Significant TR reduction with sustained procedural success at 30-day follow-up were associated with functional and clinical improvement. Transthoracic echocardiographic guidance of the procedure, thanks to excellent parasternal TV visualization, is highlighted, while the complex anatomy of the TV is pointed out. DISCUSSION: Tricuspid regurgitation is an individual predictor of morbidity but frequently found in elderly patients who are deemed very high risk for surgical treatment. This case underscores the use of modern interventional techniques and devices for addressing TR and improving QoL, whether as a stand-alone procedure or as part of complete interventional therapy of the atrioventricular valves.

Significant differences in written assessments as a result of a blended learning approach used in a clinical examination course in internal medicine: a randomized controlled pilot study.

Background: Taking a medical history and performing a physical examination represent basic medical skills. However, numerous national and international studies show that medical students and physicians-to-be demonstrate substantial deficiencies in the proper examination of individual organ systems. Aim: The objective of this study was to conduct a randomized controlled pilot study to see if, in the context of a bedside clinical examination course in internal medicine, an additional app-based blended-learning strategy resulted in (a) higher satisfaction, better self-assessments by students when rating their history-taking skills (b1) and their ability to perform physical examinations (b2), as well as (c) higher multiple-choice test scores at the end of the course, when compared to a traditional teaching strategy. Methods: Within the scope of a bedside course teaching the techniques of clinical examination, 26 students out of a total of 335 students enrolled in the 2012 summer semester and 2012/2013 winter semester were randomly assigned to two groups of the same size. Thirteen students were in an intervention group (IG) with pre- and post-material for studying via an app-based blended-learning tool, and another 13 students were in a control group (CG) with the usual pre- and post-material (handouts). The IG was given an app specifically created for the history-taking and physical exam course, an application program for smartphones enabling them to view course material directly on the smartphone. The CG received the same information in the form of paper-based notes. Prior to course begin, all of the students filled out a questionnaire on sociodemographic data and took a multiple-choice pretest with questions on anamnesis and physical examination. After completing the course, the students again took a multiple-choice test with questions on anamnesis and physical examination. Results: When compared to the CG, the IG showed significantly more improvement on the multiple-choice tests after taking the clinical examination course (p=0.022). This improvement on the MC tests in the IG significantly correlated with the amount of time spent using the app (Spearman's rho=0.741, p=0.004). Conclusion: When compared to conventional teaching, an app-based blended-learning approach leads to improvement in test scores, possibly as a result of more intensive preparation for and review of the clinical examination course material.

Outcomes of endovascular treatment for infrapopliteal peripheral artery disease based on the updated TASC II classification.

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.

Cardioprotective Potential of Human Endothelial-Colony Forming Cells from Diabetic and Nondiabetic Donors.

OBJECTIVE: The potential therapeutic role of endothelial progenitor cells (EPCs) in ischemic heart disease for myocardial repair and regeneration is subject to intense investigation. The aim of the study was to investigate the proregenerative potential of human endothelial colony-forming cells (huECFCs), a very homogenous and highly proliferative endothelial progenitor cell subpopulation, in a myocardial infarction (MI) model of severe combined immunodeficiency (SCID) mice. METHODS: CD34+ peripheral blood mononuclear cells were isolated from patient blood samples using immunomagnetic beads. For generating ECFCs, CD34+ cells were plated on fibronectin-coated dishes and were expanded by culture in endothelial-specific cell medium. Either huECFCs (5 × 105) or control medium were injected into the peri-infarct region after surgical MI induction in SCID/beige mice. Hemodynamic function was assessed invasively by conductance micromanometry 30 days post-MI. Hearts of sacrificed animals were analyzed by immunohistochemistry to assess cell fate, infarct size, and neovascularization (huECFCs n = 15 vs. control n = 10). Flow-cytometric analysis of enzymatically digested whole heart tissue was used to analyze different subsets of migrated CD34+ /CD45+ peripheral mononuclear cells as well as CD34-/CD45- cardiac-resident stem cells two days post-MI (huECFCs n = 10 vs. control n = 6). RESULTS: Transplantation of human ECFCs after MI improved left ventricular (LV) function at day 30 post-MI (LVEF: 30.43 ± 1.20% vs. 22.61 ± 1.73%, p < 0.001; ΔP/ΔTmax 5202.28 ± 316.68 mmHg/s vs. 3896.24 ± 534.95 mmHg/s, p < 0.05) when compared to controls. In addition, a significantly reduced infarct size (50.3 ± 4.5% vs. 66.1 ± 4.3%, p < 0.05) was seen in huECFC treated animals compared to controls. Immunohistochemistry failed to show integration and survival of transplanted cells. However, anti-CD31 immunohistochemistry demonstrated an increased vascular density within the infarct border zone (8.6 ± 0.4 CD31+ capillaries per HPF vs. 6.2 ± 0.5 CD31+ capillaries per HPF, p < 0.001). Flow cytometry at day two post-MI showed a trend towards increased myocardial homing of CD45+ /CD34+ mononuclear cells (1.1 ± 0.3% vs. 0.7 ± 0.1%, p = 0.2). Interestingly, we detected a significant increase in the population of CD34-/CD45-/Sca1+ cardiac resident stem cells (11.7 ± 1.7% vs. 4.7 ± 1.7%, p < 0.01). In a subgroup analysis no significant differences were seen in the cardioprotective effects of huECFCs derived from diabetic or nondiabetic patients. CONCLUSIONS: In a murine model of myocardial infarction in SCID mice, transplantation of huECFCs ameliorated myocardial function by attenuation of adverse post-MI remodeling, presumably through paracrine effects. Cardiac repair is enhanced by increasing myocardial neovascularization and the pool of Sca1+ cardiac resident stem cells. The use of huECFCs for treating ischemic heart disease warrants further investigation.

Incidence and predictors of stent thrombosis after endovascular revascularisation of the superficial femoral artery.

AIMS: The aims of this study were to assess the incidence and predictors of superficial femoral artery (SFA) stent thrombosis (ST) in a large patient cohort. METHODS AND RESULTS: A total of 984 stented SFA lesions were retrospectively analysed in 717 patients. We observed an overall ST rate of 7.5% (74/984): 14% occurred early within 30 days after stenting, 51% during the first year thereafter and 35% later than one year. The estimated five-year probability of ST was 13.4% (95% confidence interval [CI]: 10.0% to 16.7%). Significant predictors of ST were stent length (hazard ratio [HR] 1.09, 95% CI: 1.06 to 1.11, p<0.001), lesion length (HR 1.10, 95% CI: 1.08 to 1.13, p<0.001), female gender (HR 1.79, 95% CI: 1.12 to 2.86, p=0.015), chronic total occlusion (CTO) (HR 4.21, 95% CI: 2.51 to 7.05, p<0.001), implantation of more than one stent (two stents: HR 6.06, 95% CI: 3.35 to 11.0, p<0.001; three or more stents: HR 16.83, 95% CI: 9.43 to 30.0, p<0.001) as well as lesion complexity criteria as expressed by TASC II C/D (HR 17.7, 95% CI: 5.56 to 56.1, p<0.001). CONCLUSIONS: ST after SFA stenting was a common adverse event in our cohort and peaked during the first year after stent implantation. Independent predictors of ST included lesion length and stent length, female gender, presence of CTO, number of implanted stents and lesion complexity.

Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis.

BACKGROUND: The optimal revascularization therapy for in-stent restenosis (ISR) of femoropopliteal arteries represents a matter of debate. We investigated the outcomes of patients treated with drug-coated balloon (DCB) angioplasty for ISR of femoropopliteal arteries. METHODS AND RESULTS: Patient-level data from 3 randomized trials of DCB angioplasty for ISR of femoropopliteal arteries were pooled. The primary outcome was target lesion revascularization. The main secondary outcome was recurrent ISR. Other outcomes of interest were ipsilateral amputation, death, Rutherford class improvement, and ankle-brachial index at follow-up. A total of 263 patients randomly assigned to DCB (n=133) or plain balloon angioplasty (n=130) were included in the analysis. After a follow-up of 12 months, patients treated with DCB angioplasty displayed a lower risk for target lesion revascularization (hazard ratio [95% CIs]: 0.25 [0.14-0.46]; P<0.001) and recurrent ISR (0.19 [0.10-0.35]; P<0.001) as compared with those treated with plain balloon angioplasty. There was no significant interaction between the treatment effect for target lesion revascularization and high-risk subgroups of patients such as those with diabetes mellitus, longer lesions, small vessels, moderate to severe underlying calcification, and occlusive pattern of ISR. DCB and plain balloon angioplasty were comparable with respect to other secondary outcomes. CONCLUSIONS: In case of femoropopliteal ISR, the percutaneous treatment with DCB angioplasty is associated with superior clinical and antirestenotic efficacy as compared with plain balloon angioplasty at 1-year follow-up, without attrition of efficacy in high-risk subgroups of patients. The long-term durability of DCB angioplasty in this setting remains to be further investigated.

Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women.

BACKGROUND: The value of vascular closure devices (VCD) in women undergoing transfemoral catheterization has not been sufficiently investigated. METHODS AND RESULTS: This is a sex-specific analysis of 1395 women enrolled in a large-scale, randomized, multicenter trial, in which patients undergoing transfemoral diagnostic coronary angiography were randomly assigned in a 1:1:1 ratio to arteriotomy closure with an intravascular VCD, extravascular VCD, or manual compression (MC). Primary objective was to assess the safety and efficacy of 2 different VCD compared with MC regarding vascular access-site complications at 30 days. A secondary comparison was between 2 different types of contemporary VCD. Overall, women were at higher risk for vascular access-site complications compared with men (9.0% versus 6.4%; P=0.002). Vascular access-site complications were comparable in women assigned to VCD and MC (8.6% versus 9.8%; P=0.451). There was no interaction of treatment effect and sex ( Pinteraction=0.970). Time to hemostasis was significantly shortened with VCD compared with MC (1 [interquartile range, 0.5-2.0] minutes) versus 11 [interquartile range, 10-15] minutes; P<0.001); however, more women with VCD required repeat MC (2.4% versus 0.6%; P=0.018). The use of the intravascular compared with the extravascular VCD was associated with a numerical reduction in vascular access-site complications (6.6% versus 10.7%; P=0.027) and significant reductions in time to hemostasis and VCD failure. CONCLUSIONS: In women undergoing diagnostic coronary angiography via the common femoral artery, VCD and MC provided comparable safety, while time to hemostasis was reduced with VCD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01389375.

Ultrasound-guided thrombin injection for treatment of femoral artery pseudoaneurysm with concomitant AV-fistula - a retrospective single centre experience.

BACKGROUND: Increasing volume of complex percutaneous endovascular procedures in highly anticoagulated patients generate a not negligible percentage of femoral pseudoaneurysms (PSA) with concomitant arteriovenous fistulas (AVF). While ultrasound-guided thrombin injection (UGTI) is the therapy of choice for PSA, concomitant AVF is regarded as a contraindication for UGTI, as venous thromboembolism is feared. In this retrospective, register-based cohort study, we report on and evaluate the use of UGTI for the treatment of PSA with AFV. PATIENTS AND METHODS: All patients (n = 523), who underwent UGTI for femoral PSA at the German Heart Centre Munich from January 2011 until January 2018, were retrospectively reviewed for the presence of a concomitant AVF and outcomes were recorded. RESULTS: Forty femoral PSA/AVFs treated by UGTI were identified. The mean enddiastolic arterial-flow-velocity above the AVF, an estimate of the AVF size, was 14.61 ± 1.7 cm/sec. The Majority of patients exhibited flow-velocities < 25 cm/sec (n = 31; 77.5 %) and were on either uninterrupted oral anticoagulation (n = 32; 80 %) or dual antiplatelet therapy (n = 8). Twenty-eight (70 %) PSA/AVFs could be successfully closed by UGTI. In eight multicompartmental PSAs, partial obliteration necessitated combined treatment with manual compression, while one partial occlusion was treated by observation. There were three failures, of which two underwent covered-stent-graft-implantation and one surgical repair. One DVT (2.5 %) occurred two days after UGTI in the by far largest AVF (60 cm/sec) included in the study. Besides two late PSA recurrences treated by surgery, no other complications were observed. AVF persisted in 65 %, all of them asymptomatic. The mean follow-up was 6 ± 15.5 months. CONCLUSIONS: UGTI appears to be a treatment option in femoral PSA/AVF, at least under oral anticoagulation in small fistulas with enddiastolic arterial-flow-velocities ≤ 25 cm/sec. However, caution is necessary in larger AVFs, which should remain a contraindication for UGTI.